A Phase 3 interventional study of canakinumab and canakinumab-matching placebo in Non-small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals. Terminated at 152 sites in 41 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis — 8 open to participants now, 15 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Novartis.
Among the 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis, this one is the 4th largest by enrollment of the 93 interventional ones that give a count, is one of 10 that started in 2018, is one of 16 in phase 3, and was the 64th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →8 of the 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Australia, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in Netherlands
Ages 18–100
Novartis Pharmaceuticals · Sites in Denmark, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Australia, Canada and 1 more country
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Canada, Denmark and 4 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
102 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 40 · Phase 3 16 · Phase 4 3
First in 1998; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 673 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 93 across the 93 interventional studies, 109 across the 5 observational. Of the 78 that completed or were terminated, 39 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
6 of the studies in Carcinoma, Non-Small-Cell Lung by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04699188Novartis PharmaceuticalsStudy of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation | 2027-01-25 |
| NCT02393625Novartis PharmaceuticalsStudy of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer | 2027-04-09 |
| NCT03891953Novartis PharmaceuticalsStudy of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. | 2027-06-25 |
| NCT03333343Novartis PharmaceuticalsStudy of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC | 2027-07-12 |
| NCT03040973Novartis PharmaceuticalsStudy to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone | 2027-07-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis, from their registry updates:
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This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.
The study primarily assessed the safety and tolerability (safety run-in Part A) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab, and then, the efficacy (double-blind, randomized, placebo-controlled Part B) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.
Key inclusion criteria:
Key exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed.
Drug: canakinumab · Drug: pembrolizumab · Drug: carboplatin · Drug: pemetrexed
Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed.
Drug: canakinumab · Drug: pembrolizumab · Drug: cisplatin · Drug: pemetrexed
Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel.
Drug: canakinumab · Drug: pembrolizumab · Drug: carboplatin · Drug: paclitaxel
Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy.
Drug: canakinumab · Drug: pembrolizumab · Drug: carboplatin · Drug: cisplatin · Drug: paclitaxel · Drug: nab-paclitaxel · Drug: pemetrexed
Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy.
Drug: canakinumab-matching placebo · Drug: pembrolizumab · Drug: carboplatin · Drug: cisplatin · Drug: paclitaxel · Drug: nab-paclitaxel · Drug: pemetrexed
canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)
Also known as: ACZ885
canakinumab placebo every 3 weeks (squamous and non-squamous)
200 mg every 3 weeks (squamous and non-squamous)
Area Under the Curve (AUC) 5 mg/mL\*min every 3 weeks (non-squamous) or AUC 6 mg/mL\*min (squamous)
75 mg/m\^2 every 3 weeks (non-squamous)
200 mg/m\^2 every 3 weeks (squamous)
100 mg/m\^2 on Days 1, 8, and 15 of every cycle (squamous)
500 mg/m\^2 every 3 weeks (non-squamous)
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Time frame: During the first 42 days of dosing
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.
Time frame: 18 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Overall survival is defined as the time from date of randomization to date of death due to any cause.
Time frame: Up to approximately 32 months
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 26 months
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time frame: Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Time frame: Up to approximately 26 months
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 26 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1
Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Time frame: Up to approximately 26 months
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Time frame: Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Time frame: Up to approximately 26 months
Part 1 (Safety run-in): Antidrug Antibodies (ADAs) of Pembrolizumab
Participants with at least one ADA-positive sample.
Time frame: Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab
Participants with at least one ADA-positive sample.
Time frame: Up to approximately 26 months
Part 1 (Safety Run-in): Serum Canakinumab Concentration
Time frame: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration
Time frame: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration
Time frame: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration
Time frame: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration
Time frame: Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration
Time frame: Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Cisplatin Concentration
Time frame: Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration
Time frame: Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)
Part 1 (Safety Run-in): Plasma Carboplatin Concentration
Time frame: Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration
Time frame: Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration
Time frame: Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration
Time frame: Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration
Time frame: Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.\<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.
Time frame: Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.
Time frame: Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline
Time frame: Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS)
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline
Time frame: Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
| Milestone | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|---|---|---|
| Started | 10 | 11 | 9 | 320 | 323 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 10 | 11 | 9 | 320 | 323 |
| Withdrew: Progressive disease | 9 | 5 | 5 | 149 | 148 |
| Withdrew: Physician decision | 0 | 2 | 3 | 19 | 13 |
| Withdrew: Adverse event | 1 | 1 | 0 | 28 | 29 |
| Withdrew: Death | 0 | 1 | 0 | 35 | 48 |
| Withdrew: Subject decision | 0 | 1 | 0 | 12 | 12 |
| Withdrew: No treated | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Treatment ongoing | 0 | 1 | 1 | 76 | 71 |
| Withdrew: Guardian decision | 0 | 0 | 0 | 1 | 1 |
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
| Participants | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C |
|---|---|---|---|
| Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs) | 0 | 0 | 1 |
Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.
| months | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1 | 6.77 (5.62 to 7.75) | 6.77 (5.52 to 6.93) |
Overall survival is defined as the time from date of randomization to date of death due to any cause.
| months | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1 | 20.83 (16.26 to NA) | 20.17 (16.23 to 22.37) |
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| percentage of participants | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C |
|---|---|---|---|
| Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | 20.0 (2.5 to 55.6) | 72.7 (39.0 to 94.0) | 44.4 (13.7 to 78.8) |
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| percentage of participants | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1 | 45.6 (40.1 to 51.3) | 45.5 (40.0 to 51.1) |
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
| percentage of participants | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C |
|---|---|---|---|
| Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1 | 70.0 (34.8 to 93.3) | 81.8 (48.2 to 97.7) | 77.8 (40.0 to 97.2) |
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
| percentage of participants | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1 | 86.9 (82.7 to 90.4) | 84.8 (80.4 to 88.6) |
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| months | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C |
|---|---|---|---|
| Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1 | 7.43 (4.93 to NA) | 18.50 (6.34 to NA) | 8.15 (5.55 to NA) |
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| months | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1 | 14.26 (10.41 to NA) | 13.60 (10.32 to NA) |
Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
| months | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1 | NA (8.94 to NA) | NA (4.99 to NA) |
Participants with at least one ADA-positive sample.
Results for this outcome have not been posted.
Participants with at least one ADA-positive sample.
| Participants | Part 2: Canakinumab+Pembro+CTx |
|---|---|
| Baseline | 3 |
| On treatment | 2 |
Participants with at least one ADA-positive sample.
Results for this outcome have not been posted.
Participants with at least one ADA-positive sample.
| Participants | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Baseline | 2 | 1 |
| On treatment | 7 | 2 |
| μg/mL | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C |
|---|---|---|---|
| Cycle 1, Day 1, 0 hour n=9,11,9 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, 24 hour n=8,11,9 | 4.43 ± 72.1 | 4.97 ± 113.5 | 4.57 ± 67.1 |
| Cycle 1, Day 1, 168 hour n=9,11,9 | 12.1 ± 44.5 | 14.0 ± 61.7 | 12.8 ± 33.2 |
| Cycle 1, Day 1, 336 hour n=8,10,8 | 11.1 ± 35.0 | 12.3 ± 55.2 | 10.9 ± 35.9 |
| Cycle 2, Day 1, 0 hour n=9,9,7 | 10.2 ± 33.6 | 8.80 ± 49.4 | 8.69 ± 34.5 |
| Cycle 3, Day 1, 0 hour n=7,9,8 | 16.9 ± 31.3 | 20.3 ± 40.3 | 17.1 ± 16.4 |
| Cycle 4, Day 1, 0 hour n=8,8,6 | 23.1 ± 29.0 | 26.6 ± 35.0 | 19.4 ± 29.2 |
| Cycle 5, Day 1, 0 hour n=4,7,6 | 26.9 ± 41.8 | 35.6 ± 47.6 | 22.4 ± 39.0 |
| Cycle 5, Day 1, 168 hour n=5,9,4 | 32.1 ± 33.1 | 49.8 ± 42.5 | 32.7 ± 22.7 |
| Cycle 6, Day 1, 0 hour n=3,7,6 | 32.2 ± 40.0 | 36.8 ± 47.8 | 26.3 ± 27.4 |
| Cycle 8, Day 1, 0 hour n=3,7,4 | 37.7 ± 27.5 | 45.8 ± 38.6 | 29.9 ± 29.6 |
| Cycle 12, Day 1, 0 hour n=2,6,4 | 40.6 ± 90.4 | 52.2 ± 42.9 | 32.4 ± 41.0 |
| Cycle 16, Day 1, 0 hour n=1,5,4 | 68.2 ± 0 | 41.8 ± 67.3 | 31.0 ± 35.0 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx |
|---|---|
| Cycle 1, Day 1, 0 hour n=291 | 0 ± 0 |
| Cycle 1, Day 1, 24 hour n=263 | 5.36 ± 99.3 |
| Cycle 1, Day 1, 168 hour n=271 | 12.3 ± 52.1 |
| Cycle 1, Day 1, 336 hour n=272 | 10.8 ± 47.2 |
| Cycle 2, Day 1, 0 hour n=228 | 8.82 ± 46.8 |
| Cycle 3, Day 1, 0 hour n=181 | 15.2 ± 40.1 |
| Cycle 4, Day 1, 0 hour n=166 | 18.6 ± 44.4 |
| Cycle 5, Day 1, 0 hour n=154 | 22.5 ± 42.9 |
| Cycle 5, Day 1, 168 hour n=174 | 33.8 ± 42.2 |
| Cycle 6, Day 1, 0 hour n=181 | 25.0 ± 47.5 |
| Cycle 8, Day 1, 0 hour n=144 | 29.0 ± 46.9 |
| Cycle 12, Day 1, 0 hour n=124 | 32.3 ± 49.8 |
| Cycle 16, Day 1, 0 hour n=91 | 33.0 ± 49.0 |
| μg/mL | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C |
|---|---|---|---|
| Cycle 1, Day 1, 0 hour n=9,11,9 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, end-of-infusion, n=9,11,7 | 53.9 ± 29.8 | 52.9 ± 41.9 | 48.1 ± 17.7 |
| Cycle 1, Day 1, 24 hour n=7,11,9 | 40.5 ± 26.7 | 43.0 ± 35.1 | 41.4 ± 23.4 |
| Cycle 1, Day 1, 168 hour n=9,11,9 | 19.0 ± 49.4 | 21.7 ± 42.9 | 18.7 ± 17.3 |
| Cycle 1, Day 1, 336 hour n=9,11,8 | 15.1 ± 28.8 | 14.7 ± 40.6 | 12.5 ± 25.5 |
| Cycle 2, Day 1, 0 hour n=9,9,7 | 12.2 ± 36.3 | 14.5 ± 49.2 | 10.5 ± 13.0 |
| Cycle 3, Day 1, 0 hour n=7,9,7 | 21.0 ± 38.2 | 22.5 ± 46.8 | 15.5 ± 27.2 |
| Cycle 4, Day 1, 0 hour n=8,8,6 | 27.8 ± 31.4 | 33.0 ± 108.5 | 23.5 ± 37.2 |
| Cycle 5, Day 1, 0 hour n=5,7,6 | 28.6 ± 31.9 | 35.5 ± 44.3 | 28.5 ± 82.0 |
| Cycle 5, Day 1, end-of-infusion n=5,7,5 | 77.7 ± 19.7 | 99.3 ± 29.6 | 57.4 ± 51.5 |
| Cycle 6, Day 1, 0 hour n=2,7,5 | 30.6 ± 68.8 | 37.0 ± 33.6 | 26.6 ± 31.2 |
| Cycle 8, Day 1, 0 hour n=3,7,3 | 46.4 ± 16.2 | 45.3 ± 43.8 | 35.0 ± 52.0 |
| Cycle 12, Day 1, 0 hour n=1,7,1 | 76.1 ± 0 | 42.9 ± 68.8 | 20.5 ± 0 |
| Cycle 16, Day 1, 0 hour n=1,5,1 | 39.8 ± 0 | 43.4 ± 84.5 | 27.2 ± 0 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Cycle 1, Day 1, 0 hours n=29,28 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, end-of-infusion, n=27,27 | 53.5 ± 55.1 | 50.9 ± 36.0 |
| Cycle 1, Day 1, 24 hours n=29,31 | 45.9 ± 23.6 | 43.7 ± 51.8 |
| Cycle 1, Day 1, 168 hours n=28,29 | 21.5 ± 30.1 | 21.4 ± 42.2 |
| Cycle 1, Day 1, 336 hours n=23,25 | 14.5 ± 33.8 | 14.9 ± 39.9 |
| Cycle 2, Day 1, 0 hours n=19,25 | 11.5 ± 46.6 | 12.9 ± 39.3 |
| Cycle 3, Day 1, 0 hours n=12,20 | 22.7 ± 39.8 | 20.6 ± 50.0 |
| Cycle 4, Day 1, 0 hours n=12,20 | 24.7 ± 42.5 | 27.2 ± 55.0 |
| Cycle 5, Day 1, 0 hours n=15,22 | 28.6 ± 38.6 | 26.5 ± 55.0 |
| Cycle 5, Day 1, end-of-infusion n=18,21 | 66.3 ± 42.6 | 70.9 ± 41.5 |
| Cycle 6, Day 1, 0 hours n=14,17 | 34.0 ± 69.0 | 32.2 ± 71.5 |
| Cycle 8, Day 1, 0 hours n=16,17 | 36.0 ± 53.2 | 30.1 ± 57.4 |
| Cycle 12, Day 1, 0 hours n=10,9 | 47.6 ± 27.6 | 41.9 ± 44.7 |
| Cycle 16, Day 1, 0 hours n=9,8 | 42.9 ± 39.4 | 47.0 ± 38.0 |
| μg/mL | Part 1: Cohort A | Part 1: Cohort B |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=9,11 | 0 ± 0 | 517 ± 1.4 |
| Cycle 1, Day 1, end-of-infusion, n=9,11 | 102000 ± 30.2 | 87800 ± 39.5 |
| Cycle 1, Day 1, 1 hour n=9,11 | 39000 ± 23.3 | 39000 ± 29.5 |
| Cycle 1, Day 1, 4 hours n=9,11 | 10300 ± 25.1 | 10300 ± 29.6 |
| Cycle 1, Day 1, 8 hours n=9,11 | 3180 ± 38.3 | 2340 ± 58.8 |
| Cycle 2, Day 1, Pre-infusion n=8,10 | 0 ± 0 | 0 ± 0 |
| Cycle 2, Day 1, End-of-infusion n=9,10 | 93300 ± 19.0 | 92600 ± 37.5 |
| Cycle 2, Day 1, 1 hour n=9,10 | 43600 ± 15.7 | 43500 ± 16.2 |
| Cycle 2, Day 1, 2 hours n=9,9 | 26300 ± 19.1 | 23400 ± 13.9 |
| Cycle 2, Day 1, 4 hours n=9,10 | 11100 ± 25.5 | 10800 ± 34.3 |
| Cycle 2, Day 1, 8 hours n=9,10 | 3920 ± 39.1 | 2760 ± 55.0 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=18,18 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, end-of-infusion, n=19,20 | 92000 ± 21.9 | 86400 ± 46.6 |
| Cycle 1, Day 1, 1 hour n=19,20 | 42900 ± 23.5 | 36900 ± 29.4 |
| Cycle 1, Day 1, 4 hours n=19,20 | 11700 ± 33.3 | 9390 ± 48.5 |
| Cycle 2, Day 1, Pre-infusion n=15,16 | 0 ± 0 | 0 ± 0 |
| Cycle 2, Day 1, End-of-infusion n=15,17 | 89200 ± 40.8 | 97000 ± 32.3 |
| Cycle 2, Day 1, 1 hour n=15,17 | 47600 ± 30.9 | 37300 ± 20.6 |
| Cycle 2, Day 1, 2 hours n=15,17 | 26900 ± 28.7 | 20900 ± 41.9 |
| Cycle 2, Day 1, 4 hours n=14,17 | 12500 ± 38.2 | 9880 ± 55.8 |
| μg/mL | Part 1: Cohort B |
|---|---|
| Cycle 1, Day 1, Pre-infusion n=11 | 0 ± 0 |
| Cycle 1, Day 1, end-of-infusion, n=11 | 3750 ± 130.2 |
| Cycle 1, Day 1, 2 hours n=6 | 3690 ± 248.2 |
| Cycle 1, Day 1, 4 hours n=11 | 1930 ± 35.9 |
| Cycle 1, Day 1, 8 hours n=11 | 1680 ± 22.4 |
| Cycle 2, Day 1, Pre-infusion n=10 | 235 ± 29.3 |
| Cycle 2, Day 1, End-of-infusion n=10 | 2900 ± 45.6 |
| Cycle 2, Day 1, 1.5 hours n=10 | 2100 ± 51.9 |
| Cycle 2, Day 1, 2 hours n=5 | 2650 ± 20.3 |
| Cycle 2, Day 1, 4 hours n=10 | 2070 ± 15.2 |
| Cycle 2, Day 1, 8 hours n=10 | 1750 ± 29.9 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=21,18 | 0 ± 0 | 177 ± 47.5 |
| Cycle 1, Day 1, end-of-infusion, n=20,18 | 3670 ± 49.6 | 3120 ± 20.9 |
| Cycle 1, Day 1, 2 hours n=17,18 | 2280 ± 27.8 | 2180 ± 23.5 |
| Cycle 1, Day 1, 4 hours n=17,16 | 1950 ± 11.2 | 1950 ± 17.5 |
| Cycle 2, Day 1, Pre-infusion n=20,14 | 288 ± 58.9 | 296 ± 51.7 |
| Cycle 2, Day 1, End-of-infusion n=19,13 | 3130 ± 92.0 | 2820 ± 88.2 |
| Cycle 2, Day 1, 1.5 hours n=16,12 | 2790 ± 29.9 | 2410 ± 38.3 |
| Cycle 2, Day 1, 2 hours n=16,12 | 2550 ± 22.7 | 2790 ± 23.9 |
| Cycle 2, Day 1, 4 hours n=19,11 | 2340 ± 17.4 | 2340 ± 13.7 |
| μg/mL | Part 1: Cohort A | Part 1: Cohort C |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=8,9 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, End-of-infusion, n=9,9 | 17400 ± 21.9 | 21700 ± 49.8 |
| Cycle 1, Day 1, 1 hour n=9,6 | 10400 ± 42.7 | 13300 ± 46.8 |
| Cycle 1, Day 1, 2 hours n=9,9 | 6200 ± 34.3 | 7380 ± 23.5 |
| Cycle 1, Day 1, 4 hours n=9,9 | 3380 ± 34.6 | 3970 ± 29.4 |
| Cycle 1, Day 1, 8 hours n=9,6 | 1370 ± 33.6 | 1540 ± 39.6 |
| Cycle 2, Day 1, Pre-infusion n=9,9 | 125 ± 29.7 | 120 ± 16.4 |
| Cycle 2, Day 1, End-of-infusion n=9,9 | 10300 ± 441.8 | 16200 ± 32.4 |
| Cycle 2, Day 1, 1 hour n=8,6 | 13300 ± 44.1 | 11400 ± 24.5 |
| Cycle 2, Day 1, 2 hours n=9,9 | 8080 ± 38.5 | 6620 ± 22.5 |
| Cycle 2, Day 1, 4 hours n=9,9 | 3590 ± 26.8 | 3680 ± 26.7 |
| Cycle 2, Day 1, 8 hours n=9,5 | 1670 ± 29.7 | 1800 ± 34.8 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=17,19 | 0 ± 0 | 668 ± 0 |
| Cycle 1, Day 1, End-of-infusion, n=17,23 | 13800 ± 23.4 | 16900 ± 53.6 |
| Cycle 1, Day 1, 1 hour n=14,21 | 9980 ± 40.4 | 10600 ± 35.9 |
| Cycle 1, Day 1, 2 hours n=17,23 | 7250 ± 25.0 | 6930 ± 36.3 |
| Cycle 1, Day 1, 4 hours n=16,22 | 3690 ± 26.4 | 3780 ± 46.7 |
| Cycle 2, Day 1, Pre-infusion n=11,16 | 145 ± 37.2 | 121 ± 8.6 |
| Cycle 2, Day 1, End-of-infusion n=11,18 | 14300 ± 34.8 | 13000 ± 183.5 |
| Cycle 2, Day 1, 1 hour n=10,16 | 8880 ± 23.8 | 9490 ± 213.7 |
| Cycle 2, Day 1, 2 hours n=12,18 | 6810 ± 35.3 | 7080 ± 26.5 |
| Cycle 2, Day 1, 4 hours n=11,18 | 3990 ± 34.4 | 3830 ± 37.4 |
| μg/mL | Part 1: Cohort C |
|---|---|
| Cycle 1, Day 1, Pre-infusion n=9 | 0 ± 0 |
| Cycle 1, Day 1, End-of-infusion, n=9 | 4440 ± 42.5 |
| Cycle 1, Day 1, 4 hours n=8 | 827 ± 111.3 |
| Cycle 1, Day 1, 8 hours n=9 | 310 ± 83.5 |
| Cycle 1, Day 1, 12 hours n=6 | 130 ± 78.3 |
| Cycle 2, Day 1, Pre-infusion n=7 | 0 ± 0 |
| Cycle 2, Day 1, End-of-infusion n=7 | 4940 ± 35.1 |
| Cycle 2, Day 1, 4 hours n=7 | 1090 ± 89.5 |
| Cycle 2, Day 1, 6 hours n=8 | 525 ± 74.1 |
| Cycle 2, Day 1, 8 hours n=7 | 333 ± 79.8 |
| Cycle 2, Day 1, 12 hours n=4 | 134 ± 89.7 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=12,11 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, End-of-infusion, n=13,12 | 4620 ± 97.3 | 3380 ± 116.8 |
| Cycle 1, Day 1, 4 hours n=12,11 | 1880 ± 43.5 | 1900 ± 88.4 |
| Cycle 1, Day 1, 24 hours n=10,8 | 102 ± 38.9 | 114 ± 47.4 |
| Cycle 2, Day 1, Pre-infusion n=9,8 | 0 ± 0 | 0 ± 0 |
| Cycle 2, Day 1, End-of-infusion n=10,9 | 3930 ± 41.8 | 3660 ± 75.1 |
| Cycle 2, Day 1, 4 hours n=9,9 | 1450 ± 26.6 | 1180 ± 62.6 |
| Cycle 2, Day 1, 6 hours n=7,8 | 920 ± 45.7 | 775 ± 55.0 |
| Cycle 2, Day 1, 24 hours n=10,7 | 101 ± 23.6 | 81.4 ± 27.7 |
| μg/mL | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Cycle 1, Day 1, Pre-infusion n=9,13 | 0 ± 0 | 0 ± 0 |
| Cycle 1, Day 1, End-of-infusion, n=10,15 | 2620 ± 87.5 | 2520 ± 285.4 |
| Cycle 1, Day 1, 4 hours n=10,14 | 112 ± 38.3 | 117 ± 90.2 |
| Cycle 1, Day 1, 24 hours n=4,9 | 24.2 ± 16.7 | 23.9 ± 47.8 |
| Cycle 2, Day 1, Pre-infusion n=7,8 | 0 ± 0 | 44.6 ± 160.1 |
| Cycle 2, Day 1, End-of-infusion n=7,8 | 1630 ± 92.1 | 3440 ± 79.1 |
| Cycle 2, Day 1, 4 hours n=6,8 | 83.6 ± 45.5 | 96.5 ± 63.8 |
| Cycle 2, Day 1, 6 hours n=6,8 | 75.6 ± 47.1 | 86.1 ± 55.2 |
| Cycle 2, Day 1, 24 hours n=5,7 | 34.5 ± 107.7 | 23.6 ± 39.2 |
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.\<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.
| months | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Chest Pain n=65,96 | NA (NA to NA) | 22.14 (18.40 to NA) |
| Cough n=63,94 | NA (NA to NA) | 23.06 (17.51 to NA) |
| Dyspnea n=111,149 | 19.61 (13.50 to NA) | 11.50 (7.66 to 15.90) |
The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.
| months | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| Quality of Life n=119, 129 | 17.54 (14.06 to NA) | 15.90 (11.40 to 20.04) |
| Shortness of Breath n=83,115 | NA (NA to NA) | 19.29 (14.13 to 21.62) |
| Pain n=117,122 | 20.07 (13.24 to NA) | 17.91 (12.65 to 22.11) |
The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline
| score on a scale | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| CFB at Week 3 n=254,249 | 0.766 ± 0.2138 | 0.768 ± 0.2153 |
| CFB at Week 6 n=236,230 | 0.029 ± 0.2135 | 0.032 ± 0.2317 |
| CFB at Week 9 n=220,219 | 0.019 ± 0.2074 | 0.059 ± 0.2512 |
| CFB at Week 12 n=192,214 | 0.028 ± 0.2101 | 0.044 ± 0.2486 |
| CFB at Week 15 n=194,196 | 0.031 ± 0.2103 | 0.039 ± 0.2512 |
| CFB at Week 18 n=187,198 | 0.020 ± 0.2192 | 0.050 ± 0.2723 |
| CFB at Week 21 n=173,176 | 0.016 ± 0.2291 | 0.041 ± 0.2533 |
| CFB at Week 24 n=160,164 | 0.027 ± 0.2062 | 0.050 ± 0.2824 |
| CFB at Week 27 n=157,155 | 0.020 ± 0.1929 | 0.043 ± 0.2828 |
| CFB at Week 30 n=140,145 | 0.047 ± 0.1928 | 0.046 ± 0.2897 |
| CFB at Week 33 n=136,124 | 0.036 ± 0.1996 | 0.055 ± 0.2595 |
| CFB at Week 36 n=129,119 | 0.061 ± 0.1767 | 0.054 ± 0.2881 |
| CFB at Week 39 n=133,119 | 0.037 ± 0.2015 | 0.071 ± 0.2816 |
| CFB at Week 42 n=124,102 | 0.044 ± 0.1794 | 0.063 ± 0.2680 |
| CFB at Week 45 n=124,100 | 0.035 ± 0.1961 | 0.065 ± 0.2584 |
| CFB at Week 48 n=111,105 | 0.056 ± 0.1870 | 0.081 ± 0.2603 |
| CFB at Week 51 n=103,95 | 0.026 ± 0.1682 | 0.067 ± 0.2840 |
| CFB at Week 54 n=104,90 | 0.043 ± 0.1703 | 0.054 ± 0.3086 |
| CFB at Week 57 n=109,86 | 0.037 ± 0.2012 | 0.049 ± 0.2979 |
| CFB at Week 60 n=94,84 | 0.022 ± 0.2119 | 0.069 ± 0.2819 |
| CFB at Week 63 n=94,76 | 0.034 ± 0.2056 | 0.082 ± 0.3043 |
| CFB at Week 66 n=89,79 | 0.026 ± 0.2011 | 0.071 ± 0.2996 |
| CFB at Week 69 n=93,74 | 0.052 ± 0.1805 | 0.061 ± 0.2964 |
| CFB at Week 72 n=87,70 | 0.032 ± 0.1890 | 0.057 ± 0.3176 |
| CFB at Week 75 n=78,69 | 0.021 ± 0.1797 | 0.080 ± 0.2966 |
| CFB at Week 78 n=77,64 | 0.027 ± 0.1979 | 0.056 ± 0.3064 |
| CFB at Week 81 n=73,61 | 0.035 ± 0.1844 | 0.042 ± 0.3529 |
| CFB at Week 84 n=63,59 | 0.056 ± 0.1923 | 0.064 ± 0.3125 |
| CFB at Week 87 n=44,43 | 0.049 ± 0.1894 | 0.057 ± 0.3474 |
| CFB at Week 90 n=37,30 | 0.050 ± 0.1610 | 0.039 ± 0.3502 |
| CFB at Week 93 n=24,24 | 0.082 ± 0.1861 | 0.074 ± 0.4112 |
| CFB at Week 96 n=19,14 | 0.071 ± 0.1604 | 0.018 ± 0.3986 |
| CFB at Week 99 n=15,9 | 0.116 ± 0.1755 | 0.099 ± 0.4211 |
| CFB at Week 102 n=8,4 | 0.144 ± 0.1730 | -0.002 ± 0.4701 |
| CFB at Week 105 n=5,2 | 0.073 ± 0.1476 | -0.232 ± 0.2489 |
| CFB at Week 108 n=1,0 | 0.121 ± NA | — |
| CFB at Efficacy Follow-up 1 n=9,10 | -0.085 ± 0.2034 | -0.153 ± 0.4494 |
| CFB at Efficacy Follow-up 2 n=2,4 | -0.031 ± 0.6781 | -0.195 ± 0.4873 |
| CFB at Efficacy Follow-up 3 n=2,1 | 0.406 ± 0.4349 | 0.163 ± NA |
| CFB at Efficacy Follow-up 4 n=0,1 | — | 0.292 ± NA |
| CFB at CFB at Efficacy Follow-up 5 n=1,0 | -0.144 ± NA | — |
| CFB at Post-disease Progression (7 days) n=32,24 | -0.126 ± 0.2115 | -0.048 ± 0.2844 |
| CFB at Post-disease Progression (28 days) n=30,30 | -0.031 ± 0.2191 | -0.010 ± 0.2854 |
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline
| score on a scale | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|
| CFB at Week 3 n=254,249 | 0.1 ± 16.51 | 3.2 ± 18.35 |
| CFB at Week 6 n=236,230 | 1.3 ± 16.04 | 2.6 ± 18.18 |
| CFB at Week 9 n=220,219 | 1.4 ± 15.23 | 2.5 ± 17.22 |
| CFB at Week 12 n=192,214 | 0.0 ± 18.28 | 3.3 ± 16.78 |
| CFB at Week 15 n=194,196 | 0.8 ± 17.41 | 2.7 ± 18.72 |
| CFB at Week 18 n=187,198 | 0.4 ± 16.76 | 4.4 ± 17.66 |
| CFB at Week 21 n=173,176 | 0.0 ± 16.92 | 2.3 ± 18.49 |
| CFB at Week 24 n=161,164 | 0.4 ± 17.15 | 2.3 ± 19.40 |
| CFB at Week 27 n=158,155 | 0.1 ± 16.38 | 2.8 ± 17.65 |
| CFB at Week 30 n=141,145 | 0.7 ± 16.45 | 2.5 ± 19.08 |
| CFB at Week 33 n=137,124 | 0.8 ± 14.50 | 4.1 ± 17.00 |
| CFB at Week 36 n=130,119 | 2.3 ± 14.79 | 4.8 ± 16.73 |
| CFB at Week 39 n=134,119 | 2.2 ± 15.25 | 4.6 ± 16.68 |
| CFB at Week 42 n=125,103 | 1.5 ± 15.15 | 4.7 ± 17.17 |
| CFB at Week 45 n=125,100 | 1.2 ± 16.15 | 5.0 ± 14.75 |
| CFB at Week 48 n=112,105 | 0.9 ± 16.62 | 3.9 ± 17.29 |
| CFB at Week 51 n=104,95 | 0.8 ± 15.94 | 2.8 ± 17.07 |
| CFB at Week 54 n=104,90 | 0.5 ± 14.43 | 4.2 ± 17.50 |
| CFB at Week 57 n=110,86 | 0.2 ± 16.63 | 2.1 ± 19.12 |
| CFB at Week 60 n=95,84 | -1.4 ± 16.49 | 2.8 ± 17.46 |
| CFB at Week 63 n=95,76 | 0.0 ± 17.35 | 3.0 ± 20.02 |
| CFB at Week 66 n=90,79 | 1.0 ± 15.49 | 4.6 ± 19.36 |
| CFB at Week 69 n=94,74 | 1.9 ± 15.48 | 5.6 ± 18.30 |
| CFB at Week 72 n=88,70 | 0.4 ± 15.30 | 3.6 ± 19.21 |
| CFB at Week 75 n=79,69 | -0.1 ± 15.96 | 5.1 ± 19.12 |
| CFB at Week 78 n=78,64 | 0.1 ± 17.65 | 5.1 ± 19.34 |
| CFB at Week 81 n=73,61 | 0.2 ± 16.10 | 3.1 ± 19.38 |
| CFB at Week 84 n=64,59 | 2.0 ± 16.33 | 2.0 ± 19.05 |
| CFB at Week 87 n=44,43 | 0.6 ± 17.07 | 1.7 ± 18.35 |
| CFB at Week 90 n=37,30 | -1.9 ± 17.04 | 2.6 ± 18.13 |
| CFB at Week 93 n=24,24 | 1.9 ± 16.06 | 0.7 ± 16.75 |
| CFB at Week 96 n=19,14 | 2.9 ± 15.01 | 4.8 ± 16.28 |
| CFB at Week 99 n=15,9 | -1.2 ± 12.09 | 5.9 ± 19.51 |
| CFB at Week 102 n=8,4 | 5.3 ± 14.98 | 0.5 ± 21.63 |
| CFB at Week 105 n=5,2 | 7.2 ± 19.49 | -15.5 ± 7.78 |
| CFB at Week 108 n=1,0 | 3.0 ± NA | — |
| CFB at Efficacy Follow-up 1 n=9,10 | -1.6 ± 17.67 | -9.8 ± 27.85 |
| CFB at Efficacy Follow-up 2 n=2,4 | 8.5 ± 9.19 | -5.3 ± 17.23 |
| CFB at Efficacy Follow-up 3 n=2,1 | 12.5 ± 19.09 | 5.0 ± NA |
| CFB at Efficacy Follow-up 4 n=0,1 | — | 21.0 ± NA |
| CFB at CFB at Efficacy Follow-up 5 n=1,0 | 0.0 ± NA | — |
| CFB at Post-disease Progression (7 days) n=32,24 | -10.4 ± 18.36 | -4.6 ± 21.40 |
| CFB at Post-disease Progression (28 days) n=30,30 | -0.1 ± 19.14 | -1.4 ± 22.92 |
On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date.
| Participants | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx |
|---|---|---|---|---|---|
| Pre-treatment deaths | 0 | 0 | 0 | 0 | 0 |
| On-treatment deaths | 4 | 1 | 4 | 97 | 102 |
| Post-treatment survival follow-up deaths | 2 | 5 | 3 | 50 | 57 |
| All deaths | 6 | 6 | 7 | 147 | 159 |
Collected over Adverse events (AEs) were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 32 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Cohort A (On-treatment) | 4/10 (40%) | 4/10 (40%) | 10/10 (100%) |
| Part 1: Cohort B (On-treatment) | 1/11 (9.1%) | 3/11 (27.3%) | 11/11 (100%) |
| Part 1: Cohort C (On-treatment) | 4/9 (44.4%) | 4/9 (44.4%) | 9/9 (100%) |
| Part 2: Canakinumab+Pembro+CTx (On-treatment) | 97/320 (30.3%) | 174/320 (54.4%) | 309/320 (96.6%) |
| Part 2: Placebo+Pembro+CTx (On-treatment) | 102/323 (31.6%) | 167/322 (51.9%) | 310/322 (96.3%) |
| Part 1: Cohort A (Post-treatment Survival Follow-up) | 2/6 (33.3%) | — | — |
| Part 1: Cohort B (Post-treatment Survival Follow-up) | 5/10 (50%) | — | — |
| Part 1: Cohort C (Post-treatment Survival Follow-up) | 3/5 (60%) | — | — |
| Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) | 50/223 (22.4%) | — | — |
| Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) | 57/220 (25.9%) | — | — |
| Event | Part 1: Cohort A (On-treatment) | Part 1: Cohort B (On-treatment) | Part 1: Cohort C (On-treatment) | Part 2: Canakinumab+Pembro+CTx (On-treatment) | Part 2: Placebo+Pembro+CTx (On-treatment) | Part 1: Cohort A (Post-treatment Survival Follow-up) | Part 1: Cohort B (Post-treatment Survival Follow-up) | Part 1: Cohort C (Post-treatment Survival Follow-up) | Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) | Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) |
|---|---|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 2/10 | 0/11 | 0/9 | 2/320 | 3/322 | — | — | — | — | — |
| Atrial fibrillationCardiac disorders | 0/10 | 0/11 | 1/9 | 0/320 | 3/322 | — | — | — | — | — |
| Atrial flutterCardiac disorders | 0/10 | 0/11 | 1/9 | 0/320 | 1/322 | — | — | — | — | — |
| DiarrhoeaGastrointestinal disorders | 0/10 | 0/11 | 1/9 | 7/320 | 10/322 | — | — | — | — | — |
| PyrexiaGeneral disorders | 0/10 | 0/11 | 1/9 | 12/320 | 8/322 | — | — | — | — | — |
| HepatitisHepatobiliary disorders | 0/10 | 0/11 | 1/9 | 1/320 | 1/322 | — | — | — | — | — |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/10 | 0/11 | 1/9 | 0/320 | 0/322 | — | — | — | — | — |
| PolyneuropathyNervous system disorders | 0/10 | 0/11 | 1/9 | 1/320 | 0/322 | — | — | — | — | — |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/10 | 0/11 | 1/9 | 16/320 | 13/322 | — | — | — | — | — |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/10 | 0/11 | 1/9 | 8/320 | 6/322 | — | — | — | — | — |
| Event | Part 1: Cohort A (On-treatment) | Part 1: Cohort B (On-treatment) | Part 1: Cohort C (On-treatment) | Part 2: Canakinumab+Pembro+CTx (On-treatment) | Part 2: Placebo+Pembro+CTx (On-treatment) | Part 1: Cohort A (Post-treatment Survival Follow-up) | Part 1: Cohort B (Post-treatment Survival Follow-up) | Part 1: Cohort C (Post-treatment Survival Follow-up) | Part 2: Canakinumab+Pembro+CTx (Post-treatment Survival Follow-up) | Part 2: Placebo+Pembro+CTx (Post-treatment Survival Follow-up) |
|---|---|---|---|---|---|---|---|---|---|---|
| ConstipationGastrointestinal disorders | 6/10 | 3/11 | 2/9 | 84/320 | 81/322 | — | — | — | — | — |
| NauseaGastrointestinal disorders | 3/10 | 5/11 | 5/9 | 115/320 | 124/322 | — | — | — | — | — |
| AnaemiaBlood and lymphatic system disorders | 3/10 | 3/11 | 3/9 | 153/320 | 148/322 | — | — | — | — | — |
| VomitingGastrointestinal disorders | 3/10 | 5/11 | 2/9 | 54/320 | 51/322 | — | — | — | — | — |
| FatigueGeneral disorders | 2/10 | 5/11 | 3/9 | 59/320 | 68/322 | — | — | — | — | — |
| Decreased appetiteMetabolism and nutrition disorders | 3/10 | 5/11 | 1/9 | 91/320 | 79/322 | — | — | — | — | — |
| RashSkin and subcutaneous tissue disorders | 0/10 | 5/11 | 2/9 | 51/320 | 61/322 | — | — | — | — | — |
| Neuropathy peripheralNervous system disorders | 0/10 | 0/11 | 4/9 | 22/320 | 18/322 | — | — | — | — | — |
| CoughRespiratory, thoracic and mediastinal disorders | 4/10 | 3/11 | 0/9 | 54/320 | 51/322 | — | — | — | — | — |
| NeutropeniaBlood and lymphatic system disorders | 1/10 | 1/11 | 1/9 | 124/320 | 78/322 | — | — | — | — | — |
| Age, Continuous(years) | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx | Total |
|---|---|---|---|---|---|---|
| Mean | 64.5 ± 6.57 | 57.9 ± 13.03 | 63.1 ± 7.18 | 61.7 ± 9.65 | 62.7 ± 8.74 | 62.2 ± 9.23 |
| Sex: Female, Male(Participants) | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 5 | 3 | 93 | 91 | 192 |
| Male | 10 | 6 | 6 | 227 | 232 | 481 |
| Race/Ethnicity, Customized(Participants) | Part 1: Cohort A | Part 1: Cohort B | Part 1: Cohort C | Part 2: Canakinumab+Pembro+CTx | Part 2: Placebo+Pembro+CTx | Total |
|---|---|---|---|---|---|---|
| White | 5 | 3 | 7 | 185 | 180 | 380 |
| Asian | 5 | 5 | 2 | 115 | 117 | 244 |
| Black or African American | 0 | 0 | 0 | 1 | 4 | 5 |
| Multiple | 0 | 0 | 0 | 0 | 2 | 2 |
| Missing | 0 | 3 | 0 | 19 | 20 | 42 |
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Ran from Dec 2018 to primary completion in Aug 2021, 31 months.
Results were first posted in Oct 2024, 3 years 1 month after primary completion. A results delay was requested in Jul 2022.
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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Canakinumab
Carcinoma, Non-Small-Cell Lung →